Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Sodium Restriction in the Management of Cirrhotic Ascites

This study has been terminated.
(Failure to recruit.)
Information provided by:
University of Texas Southwestern Medical Center Identifier:
First received: October 22, 2007
Last updated: September 10, 2010
Last verified: September 2010

To determine the relationship between degree of sodium restriction and dietary compliance with clinical outcome of diuresis of portal hypertensive ascites in cirrhotic patients from a county hospital population.

Primary objective: Demonstrate that, when accompanied by the appropriate diuretic regimen, a No Added Salt diet (4 grams sodium per day) is as effective as a Low Sodium diet (2 grams sodium per day) in the management of cirrhotic ascites.

Condition Intervention Phase
Other: Sodium restriction
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy of 2 Gram Versus 4 Gram Sodium Restriction in the Management of Cirrhotic Ascites

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Control of ascites [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient acceptance and compliance [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: October 2007
Study Completion Date: September 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
4 gram sodium diet
Other: Sodium restriction
4 gram sodium diet
Other Name: No added salt diet
Active Comparator: 2
2 gram sodium diet
Other: Sodium restriction
2 gram sodium diet
Other Name: Low sodium diet

Detailed Description:

Secondary objectives:

  1. Demonstrate that patient acceptance is greater and diuresis faster with a No Added Salt diet compared with a Low Sodium diet
  2. Demonstrate that side-effects of diuretic therapy are the same or less when patients are on a No Added Salt diet
  3. Determine if glomerular filtration rate estimated from the modified diet in renal disease equation differs from that obtained by a 24 hour urinary creatinine in patients with cirrhotic ascites

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cirrhotic patients of any etiology with ascites from portal hypertension diagnosed by paracentesis,
  • Age 18-75
  • Clinical or radiographic (abdominal CT or ultrasound) estimate of moderate - severe ascites
  • Spanish-speaking subjects will be eligible for participation

Exclusion Criteria:

  • Active drug or alcohol abuse,
  • Active complications of SBP, hepatic encephalopathy, or GI bleed within 2 weeks,
  • Hemorrhagic ascites, malignant ascites,
  • Creatinine >2 mg/dL or CCl < 30 mL/min,
  • K > 5.5 mmol/L,
  • Diuretic refractory ascites
  • Allergy to or intolerance of either spironolactone or furosemide
  • Homelessness, incarceration, inability to follow up in clinic, or comply with diet.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00548366

United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Study Director: Jennifer A Cuthbert, M.D. UT Southwestern Medical Center at Dallas
  More Information

No publications provided

Responsible Party: Jennifer Cuthbert, UT Southwestern Medical Center at Dallas Identifier: NCT00548366     History of Changes
Other Study ID Numbers: UTSouthwestern 062007-066
Study First Received: October 22, 2007
Last Updated: September 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
portal hypertension
sodium restriction

Additional relevant MeSH terms:
Pathologic Processes processed this record on March 03, 2015